Heart failure with reduced ejection fraction heart failure
Conditions
Interventions
Randomization to limited number of kidney function assessments or standard of care
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The study population consists of adults (= 18 years old) with heart failure with reduced ejection fraction (left ventricular ejection fraction = 45%) referred to the heart failure outpatient clinic for initiation or uptitration of guideline-directed medical therapy.
Exclusion criteria
Exclusion criteria: eGFR<25 mL/min/1.73 m2, potassium > 5.5 mmol/L or <3.5 mmol/L at screening, or known intolerance or allergy to one or more guideline-directed medical therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The achieved average percentage dose of reno-active GDMT at 6 months relative to optimal dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: The achieved percentage dose of the individual reno-active GDMT drug classes at 6 months relative to optimal dose, and time to first occurrence of unplanned heart failure visit, heart failure hospitalization, or all-cause mortality till 9 months.Exploratory endpoints: The achieved average percentage dose of the all GDMT at 6 months relative to optimal dose, percentage change in NT-pro BNP at 6 months, and change in loop diuretics at 6 months.Safety endpoints: Incidence of doubling of creatinine, estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2, potassium >6 mmol/L, or potassium <3.5 mmol/L at any timepoint. An additional composite kidney endpoint is defined as a combination of hospitalization for kidney failure, dialysis or end-stage kidney disease (eGFR <15 mL/min/1.73 m2). | — |
Countries
Netherlands
Contacts
Public ContactJ.M. Maaten
Universitair Medisch Centrum Groningen
Outcome results
None listed